Quality Assurance Specialist

vor 2 Wochen

Eysins, Schweiz AliveDx Vollzeit
Quality System Engineer Job Description

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30 years of experience in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results.

Main Responsibilities:
  • Lead the end-to-end transition to an electronic Quality Management System (eQMS), ensuring alignment with ISO 13485 requirements.
  • Work closely with IT, Quality Assurance, Regulatory Affairs, and other departments to ensure seamless integration of the eQMS with existing processes and systems.
  • Ensure the eQMS meets ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulatory standards.
  • Develop and implement a comprehensive training program for end users, ensuring staff are proficient in the use of the new eQMS and drive change management.
  • Manage relationships with eQMS vendors, ensuring timely delivery of system components and services.
  • Identify potential project risks, develop mitigation strategies, and implement contingency plans to address unforeseen challenges.
Key Skills and Qualifications:
  • Bachelor's degree in Quality assurance, Engineering, Life Sciences, Information Technology, or a related field and ideally advanced degree or certifications in Quality Management, Project Management (e.g., PMP), or Regulatory Affairs.
  • Minimum of 5 years of experience in quality management or project management roles within an ISO 13485-compliant environment, preferably in the medical device or pharmaceutical industry.
  • Strong understanding of ISO 13485, FDA 21 CFR Part 820, and other regulatory requirements for medical devices.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, religion/belief, sexual orientation or age.

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